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Scientific evidence
Integrating the melanoma 31-gene expression profile test with clinical and pathologic features can provide personalized precision estimates for sentinel lymph node positivity: an independent performance cohort
Sep 2024
The i31-GEP identified patients with < 5% risk of SLN positivity who could safely forego SLNB. Combining the 31-GEP with clinicopathologic features for a precise risk estimate can help guide risk-aligned patient care decisions for SLNB to reduce the number of unnecessary SLNBs and increase the SLNB positivity yield if the procedure is performed.
Publication: World Journal of Surgical Oncology
Appropriate statistical methods to assess cross-study diagnostic 23-gene expression profile test performance for cutaneous melanocytic neoplasms
Aug 2024
MyPath Melanoma has been well studied over the past nine years in various independent and company-sponsored studies. This publication re-analyzes data from multiple previous performance studies of MyPath Melanoma using a rigorous, standardized method for statistical analysis across studies. Goldberg et al. use a mathematical bootstrapping technique to correct for small, imbalanced, and inconsistent cohort sizes across studies allowing for direct comparison between all studies. The resulting analysis not only found consistently high sensitivity, specificity, positive predictive value, and negative predictive value, but also found no statistically significant difference in performance across both independent and company-sponsored studies.
Publication: American Journal of Dermatopathology
Diagnostic discordance among histopathological reviewers of melanocytic lesions
May 2024
The management of patient with melanocytic lesions is dependent on the diagnosis with guidelines defining treatment protocols for benign nevi and malignant melanomas. Even though diagnostic discordance and diagnostic ambiguity have been previously established, the real-world impact on patient management is not well understood.Using an exhaustive review process by multiple dermatopathologists and a simulated patient treatment model, this study reveals that diagnostic discordance and ambiguity may be more common that previously reported and identifies significant variation in patient treatment in these lesions.
Publication: Journal of Cutaneous Pathology
A clinical impact study of dermatologists' use of diagnostic gene expression profile testing to guide patient management
Apr 2024
Diagnostic GEP tests help guide clinical decision-making in a variety of diagnostically ambiguous or clinicopathologically discordant scenarios.
Publication: Future Medicine
Utility of 31-gene expression profile test in identifying patients with T1 cutaneous melanoma at high risk of SLN positivity and recurrence
Mar 2024
Demonstrate that the 31-GEP offers significant prognostic value in addition to SLN status to help identify patients at the highest risk of tumor recurrence.
Publication: ePoster at SSO 2024
Prospective validation of the i31-GEP for cutaneous melanoma to select patients who may consider foregoing SLNB
Mar 2024
This study shares three-year outcomes data from Castle’s prospective, multicenter study of patients with melanoma who were being considered for an SLNB (n=322). In the study, at three years, all patients with a low-risk DecisionDx-Melanoma test result were recurrence free (recurrence free survival of 100%). The performance data shared in this presentation, in conjunction with previous validation and performance studies, show DecisionDx-Melanoma as an accurate and precise clinical tool that can identify patients who may safely forego SLNB, reducing the number of unnecessary SLNBs performed (by ~25% in this study alone) and the associated costs and risks of complications that accompany them.
Publication: Oral Presentation at SSO 2024
The 31-gene expression profile test outperforms AJCC in stratifying risk of recurrence in patients with stage I cutaneous melanoma
Jan 2024
In a head-to-head comparison of DecisionDx-Melanoma to AJCCv8 staging for stage I cutaneous melanoma (CM) patients (n=6,883) two cohorts were analyzed using recurrence-free survival and melanoma-specific survival. Results from the study showed that DecisionDx-Melanoma significantly improved patient risk stratification, independent of AJCC staging in patients. In addition, DecisionDx-Melanoma provided greater separation between high-risk (Class 2B) and low-risk (Class 1A) groups than seen between AJCC stage IA and IB.
Publication: Cancers
Diagnostic utility of the 23-gene expression profile test for an atypical intradermal melanocytic proliferation
Dec 2023
A case report describing how MyPath GEP testing leads to diagnostic clarity in a histopathologically ambiguous melanocytic lesion on the face of a 34-year-old man.
Publication: Future Medicine
A physician’s guide to the use of gene expression profile ancillary diagnostic testing for cutaneous melanocytic neoplasms
Dec 2023
Publication: Journal of Clinical and Aesthetic Dermatology
A physician’s guide to the use of gene expression profile ancillary diagnostic testing for cutaneous melanocytic neoplasms
Dec 2023
A real-world assessment of common use scenarios of MyPath GEP testing by dermatopathologists and dermatologists to achieve definitive diagnoses and personalized patient management plans.
Publication: Journal of Clinical and Aesthetic Dermatology
Performance of the 23-gene expression profile (23-GEP) test by histopathological evaluation in an independent, multi-center performance cohort of cutaneous melanocytic neoplasms
Nov 2023
Accuracy data in an independent, multi-center cohort of 2512 melanocytic lesions
Publication: Skin
31-gene xxpression profile testing in cutaneous melanoma and survival outcomes in a population-based analysis: A SEER collaboration
Jun 2023
Study data from Castle Biosciences' collaboration with the National Cancer Institutes SEER program registries.
Publication: JCO-PO